Study Summary
This trial is testing a new prostate cancer treatment that combines two drugs: one that delivers radiation to cancer cells, and one that strengthens the immune system's ability to destroy cancer cells.
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 7 Secondary · Reporting Duration: Will be collected at the time of visit 1 through 1 year on study
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Pembrolizumab + ARPI
1 of 2
Pembrolizumab + 225Ac-J591 + ARPI
1 of 2
Experimental Treatment
76 Total Participants · 2 Treatment Groups
Primary Treatment: 225Ac-J591 · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 99 · Male Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Does this experiment have an age restriction?
"This trial is for patients aged 18 to 99. However, if the patient falls outside of that age range, there are 109 studies for those under 18 and 2354 trials for seniors aged 65 and up." - Anonymous Online Contributor
How many people are allowed to take part in this experiment?
"That is accurate. The clinicaltrials.gov website has the most recent information regarding this study, which was first posted on 8/12/2021 and last updated 9/27/2022. There are 4 active recruitment sites for the 76 open participant spots." - Anonymous Online Contributor
Can new participants join this research project?
"The information available on clinicaltrials.gov indicates that this study is still recruiting patients as of September 27th, 2022. This trial was originally posted on August 12th, 2021 and has been updated several times since then. They are looking for a total of 76 participants that will be spread out between 4 different sites." - Anonymous Online Contributor
Could I potentially qualify to participate in this research study?
"Those that wish to take part in this prostate cancer clinical trial must be aged between 18 and 99. There are only 76 spots available in total." - Anonymous Online Contributor
What diseases or conditions is 225Ac-J591 commonly used as a therapy for?
"225Ac-J591 is a standard treatment for malignant neoplasms, but can also be used to ameliorate other conditions like microsatellite instability high and disease progression after chemotherapy." - Anonymous Online Contributor
Do we have precedent for using 225Ac-J591 in this way?
"City of Hope was the first institution to study 225Ac-J591 back in 2010 and there have been 251 completed trials since then. There are over a thousand studies currently recruiting, with a significant portion being based in Brooklyn, MA." - Anonymous Online Contributor
What is the intended outcome of this research?
"The purpose of this study, which will take place over the course of 100 months, is to assess the proportion of patients that experience dose-limiting toxicity following treatment with pembrolizumab and 225Ac-J591. Additionally, researchers will track changes in 1-year progression-free survival rate (defined as imaging or biochemical evidence), changes in biochemical progression-free survival rate (PSA level increase), and changes in overall survival rate." - Anonymous Online Contributor